EMA welcomes political agreement on new EU pharmaceutical legislation

The new legislation will modernise how medicines are developed, authorised and made available to patients across the EU. It is expected to simplify structures and procedures which have been introduced by different pieces of legislation over the years, namely the existing pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC) and the legislation on medicines for children and for rare diseases (Regulation 1901/2006 and Regulation 141/2000/EC, respectively). It also amends the advanced therapy medicinal products (ATMP) Regulation 1394/2007.
Key areas affected by the reform
The new pharmaceutical legislation will bring significant changes across multiple areas of EMA’s work.
Key elements include:
A simpler regulatory environment
EMA will simplify its committee structure from five to two scientific committees for human medicines: the Committee for Human Medicinal Products (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC). The new, leaner structure will be complemented by stronger support for the two committees through best available expertise. Additionally, the committees will benefit from increased patient and healthcare professional representation.
the streamlined structure facilitates reduced assessment time (210 to 180 days) and frees up scientific resources to strengthen pre-authorisation support to medicine developers.
marketing authorisation for a medicine will be valid by default for an unlimited period, avoiding the unnecessary administrative burden linked to renewals unless required on safety grounds by EMA’s scientific committees.
digital solutions: the reform will require applicants to submit marketing authorisation applications in electronic and structured formats and to make available approved product information in electronic form (ePI).
More support and improved conditions for innovation
The reform foresees important new elements for public authorities to further support innovation, such as:
the possibility for EMA to offer extended scientific advice with HTA bodies or medical device expert panels and strengthened PRIME support.
the possibility for the European Commission to establish, at the suggestion of EMA and in consultation with Member States, a regulatory sandbox to test, under the direct supervision of the competent authorities, adapted requirements for innovative medicines that cannot be developed under current rules.
the creation of adapted frameworks for certain non-standard categories of medicines, such as personalised therapies, that can provide a major contribution to patient access or patient care.
improvements in the efficiency of the process for studying medicines in children, including formalising a new process for iterative paediatric investigation plans (PIPs) already piloted by EMA.
Stronger safeguards against medicine shortages
The reform establishes several new rules for marketing authorisation holders and public health authorities to cooperate to ensure continuity of supply and availability of critical medicines in the EU, including:
stronger obligations for companies to ensure continuous supply of medicines.
the obligation to notify shortages and withdrawals in advance and have shortage prevention plans in place for prescription medicines.
monitoring of expected and actual shortages by both EMA and national competent authorities, based on notifications from marketing authorisation holders.
establishment of an EU list of critical medicines for which supply chain vulnerability assessments will be carried out.
Enhanced environmental protection and focus on antimicrobial resistance
The reform also introduces strengthened provisions on:
environmental risk assessment, including special methodologies to evaluate the risk for antimicrobial resistance selection in the environment due to the manufacture of antimicrobials.
prudent use of antimicrobials, including compulsory medical prescriptions for all antimicrobials, specific information requirements to be provided with the package leaflet, an awareness card and an antimicrobial stewardship plan to be submitted by applicants.
Next steps
The political agreement is now subject to formal approval by the European Parliament and the Council.
Over the coming months and years, once the text has been formally approved, EMA will work together with the European Commission and EU Member States, to develop relevant guidance for applicants and marketing authorisation holders to comply with the new legal framework.
To ensure the smooth implementation of the legislation, EMA’s stakeholders will be kept informed and actively involved in the implementation process on specific technical and procedural aspects of the reform.
EMA plans to publish a new web page that will serve as a gateway and central repository of information on implementation of the new legislation for EMA’s stakeholders. The webpage will be updated as implementation work progresses and guidance for pharmaceutical companies becomes available.
Background
The pharmaceutical legislation reform was proposed by the European Commission in April 2023. Over the preceding few years, EMA and the Heads of Medicines Agencies (HMA), together with experts from the scientific committees, had provided scientific and technical inputs to the European Commission based on their extensive experience in operating under the current EU pharmaceutical framework. The European Parliament adopted its position in April 2024 and the Council of the EU in June 2025.